Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. … Continue Reading
Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure.
In this instance, several data protection compliance issues were at stake – HCA had engaged a subcontractor based in India to process sensitive personal data without putting an agreement in … Continue Reading
On Wednesday, August 17, 2016, the Future of Privacy Forum (FPF) released a set of detailed guidelines for the collection and use of consumer-generated wellness data. The document, Best Practices for Consumer Wearables & Wellness Apps & Devices, was drafted by FPF with input from a wide range of stakeholders, including privacy advocates, companies, and regulators. The Best Practices… Continue Reading
On 6th July, the UK Government published two independent reviews concerning data security and data sharing in the health and care system in England. At the same time the UK Government launched a public consultation on proposals resulting from these reviews. The public consultation will be of interest to organisations that regularly interact with the public health sector in the … Continue Reading
Along with the concept of personal data, as opposed to anonymous data, the Regulation introduces a third category, that of pseudonymous data. Pseudonymous data is information that no longer allows the identification of an individual without additional information and is kept separate from it. Pseudonymisation, while granting higher data security, also enhances data utility. In exchange … Continue Reading
Following the launch of its mHealth Developer Portal last October, the HHS Office for Civil Rights (OCR) has released guidance clarifying how HIPAA applies to mobile health apps. Ensuring that developers understand their legal obligations is critical to protecting consumer privacy and security, especially now that there are more than 165,000 health apps available in the iTunes and Android app … Continue Reading
The EU General Data Protection Regulation (“GDPR”) has been called the most lobbied piece of legislation in the history of the EU. Before Christmas last year, what is likely to be the final text of the GDPR emerged from the EU trilogue negotiations. Victoria Hordern, Senior Associate at Hogan Lovells, explores what the new GDPR will mean for those collecting … Continue Reading